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The FDA Issues Class 1 Recall for Stryker’s Oasys Midline Occiput Plate Due to a Key Defect, Reports Parker Waichman LLP
Date:9/4/2013

New York, New York (PRWEB) September 04, 2013

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, reports that the U.S. Food and Drug Administration (FDA) posted an Aug. 29 safety alert to inform the public of a class 1 recall of Stryker’s Oasys Midline Occiput Plate, which is used in cervical spinal fusion surgery, based on reports that, following surgery, the pin that connects the tulip head to the plate body can break. Such a fracture could lead to destabilization of the plate, and revision surgery may be required, the FDA warned in the safety alert.

For those implanted with this device, there is the possibility of serious adverse health consequences, including blood loss and nerve injury, as well as revision surgery to replace the fractured implant, noted the FDA’s safety alert.

Class I recalls are the most serious – involving situations “in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death,” the FDA reported in the safety alert. If a patient begins suffering from symptoms such as pain, weakness, or numbness, “urgent evaluation is needed,” the FDA said in the safety alert, adding that “for patients who have had a revision surgery, Stryker recommends routine post-operative care and follow-up.”

“We hope that anyone who has had cervical spinal fusion surgery involving the implanting of Stryker’s Oasys Midline Occiput Plate becomes aware of this safety alert and takes it seriously,” said Parker Waichman LLP, a national law firm that actively investigates cases involving injuries
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